Hybrid ambulatory infusion pumps

ABSTRACT

Ambulatory infusion pumps, durable assemblies, and disposable assemblies, including energy sources, reservoirs, baseplates, and related components therefor, as well as component combinations and related methods.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims the benefit of U.S. Provisional Application Ser.No. 62/057,273, filed Sep. 30, 2014 and entitled “Hybrid AmbulatoryInfusion Pumps,” which is incorporated herein by reference in itsentirety.

BACKGROUND

1. Field

The present devices and methods relate generally to ambulatory infusionpumps.

2. Description of the Related Art

Ambulatory infusion pumps (also referred to herein simply as “infusionpumps”) are relatively small, at least substantially self-containeddevices that are used to introduce drugs and other infusible substances(collectively “medicament”) into patients' bodies. Some infusion pumpsare configured to be worn on a belt, carried in a clothing pocket, orthe like. Other infusion pumps are configured to be adhered to skin inpatch-like fashion. Infusion pumps are advantageous in that they may beused to, for example, subcutaneously introduce (or “infuse”) medicamenton an ongoing or even continuous basis outside of a clinicalenvironment. Infusion pumps are also advantageous in that they greatlyreduce the frequency of subcutaneous access events such as needle-basedshots. One example of a medicament that may be introduced by an infusionpump is a liquid formulation of insulin. Other exemplary medicamentsthat may be introduced by an infusion pump include, but are not limitedto, drugs that treat cancers and drugs that suppress the perception ofpain.

Many conventional infusion pumps have improved patient health andquality of life. Nevertheless, the present inventors have determinedthat conventional infusion pumps are susceptible to a wide range ofimprovements. By way of example, but not limitation, the presentinventors have determined that it would be desirable to provide aninfusion pump that is smaller, simpler, and less costly thanconventional infusion pumps, while still being more accurate thanconventional infusion pumps.

SUMMARY

A system in accordance with at least one of the present inventionsincludes an infusion pump durable assembly and an infusion pumpdisposable assembly. The durable assembly may include one or more energysources in a housing. The disposable assembly may include a medicamentreservoir and be configured to attach to the durable assembly. Energyfrom the energy supply may be transferred to the disposable assembly todispense medicament from the reservoir. The energy may be transferredwithout mechanical coupling or electrical contact, as byelectromechanical torque coupling.

A method in accordance with at least one of the present inventionsincludes the step of securing an infusion pump durable assembly with aenergy supply to an infusion pump disposable assembly with a medicamentreservoir such that energy from the energy supply is transferred to thedisposable assembly and transformed into mechanical forces that move aplunger within the reservoir.

A disposable assembly in accordance with at least one of the presentinventions includes a baseplate, a medicament reservoir on thebaseplate, a plunger moveable within the reservoir, a motor rotor, and agear train. The motor rotor may receive electromagnetic energy fromoutside the disposable assembly and the gear train may transform thatelectromagnetic energy to mechanical forces that move the plunger withinthe reservoir.

The features and attendant advantages of the present inventions willbecome apparent as the inventions become better understood by referenceto the following detailed description when considered in conjunctionwith the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

Detailed description of exemplary embodiments will be made withreference to the accompanying drawings.

FIG. 1A is a perspective view of an exemplary infusion pump system in anassembled state.

FIG. 1B is an exploded perspective view of the infusion pump systemillustrated in FIG. 1A, including a durable assembly and a disposableassembly.

FIG. 2 is a top view of certain components of the infusion pump systemillustrated in FIGS. 1A and 1B.

FIG. 2A is a schematic view showing a use of the infusion pump systemillustrated in FIGS. 1A and 1B.

FIG. 2B is a schematic view showing another use of the infusion pumpsystem illustrated in FIGS. 1A and 1B.

FIG. 3A is a perspective view of an exemplary durable assembly.

FIG. 3B is a perspective view of certain components of the durableassembly illustrated in FIG. 3A.

FIG. 4A is a perspective view of an exemplary disposable assembly.

FIG. 4B is a perspective view of certain components of the disposableassembly illustrated in FIG. 4A.

FIG. 5A is a perspective view of certain components of a durableassembly and a disposable assembly of an exemplary infusion pump system.

FIG. 5B is a perspective view of the components of the exemplary durableassembly illustrated in FIG. 5A.

FIG. 5C is a perspective view of the components of the exemplarydisposable assembly illustrated in FIG. 5A.

FIG. 6 is a perspective section view of components of the exemplaryinfusion pump system of FIG. 5A, revealing a gap between certaincomponents of the durable and disposable assemblies.

FIG. 7 is a front view showing a patient's skin being cleaned.

FIG. 8 is a flow chart illustrating an exemplary disposable assemblyremoval and replacement method.

FIG. 9 is a perspective view of an exemplary infusion pump system in anassembled state.

DETAILED DESCRIPTION

The following is a detailed description of the best presently knownmodes of carrying out the inventions. This description is not to betaken in a limiting sense, but is made merely for the purpose ofillustrating the general principles of the inventions.

It should also be noted here that the specification describes structuresand methods that are especially well-suited for the subcutaneousdelivery of high concentration insulin (e.g., the U-500 insulindiscussed below). Nevertheless, it should be appreciated that thepresent inventions are applicable to a wide variety of infusion pumpsand medicaments. By way of example, but not limitation, the inventionsmay employ, for fluid displacement, a reservoir with a plunger, a fluiddisplacement device in the form of a plunger pusher, and a drivemechanism that includes a motor, or other fluid displacement devices,regardless of the type of reservoir employed, piston pumps (e.g.,electromagnet pumps), MEMS pumps, peristaltic pumps and any othersuitable pumps as well as corresponding drive mechanisms. Exemplaryinfusion pumps that include a reservoir with a plunger, a fluiddisplacement device in the form of a plunger pusher, and a drivemechanism are described in U.S. patent application Ser. No. 12/890,207,filed Sep. 24, 2010, and corresponding U.S. patent publication number2012/0078170, both of which are incorporated by reference in theirentireties. The present inventions are also applicable to medicamentssuch as, for example, drugs to mask pain, chemotherapy and other cancerrelated drugs, antibiotics, hormones, GLP-1, Glucagon, various otherdrugs that include large molecules and proteins that may require a highlevel of delivery accuracy, as well as to high concentration insulin(i.e., U-200 and above) such as U-500 insulin.

As noted above, some ambulatory infusion pumps are intended to be wornon a belt, carried in a pocket, or otherwise supported within a holderof some kind (referred to collectively as “pocket pumps”). Such infusionpumps transfer fluid from a reservoir to an infusion set by way of anelongate tube. Subcutaneous access may be obtained by way of a cannulain the infusion set. Other ambulatory infusion pumps are intended to beadhered to the skin above the delivery site (sometimes referred to as“patch pumps”). Here, the cannula or other subcutaneous access devicemay extend directly from the infusion device. Given these modes of use,patients typically prefer the device to be as small as possible so it ismore comfortable, less obtrusive, and less visible. In addition,patients want a device that is easy and convenient to use.

An exemplary ambulatory infusion system, which is generally representedby reference numeral 100 in FIGS. 1A, 1B, and 2, includes a durableassembly 200 and a disposable assembly 300. Exemplary durable assembly200 includes a housing 202, one or more batteries or other energy supply221, one or more capacitors or other energy storage 222, amicroprocessor 223, a coil assembly 224 (which functions as a motorstator), and one or more Hall effect sensors 225. Exemplary disposableassembly 300 includes a baseplate 350 supporting components such as amagnetic motor rotor 331, a gear train 332 including lead screw drivegear 333, and a lead screw 334 attached to plunger 335, which ispositioned in a medicament reservoir 336. A cover 302, under which someor all of the magnetic motor rotor 331, gear train 332 (with drive gear333), lead screw 334, plunger 335, and medicament reservoir 336 arelocated in various embodiments, may be mounted to the baseplate 350.

The exemplary disposable assembly 300 may be secured to the exemplarydurable assembly 200, as shown in FIGS. 1A and 2. To that end, theexemplary housing 202 includes a top wall 204, bottom walls 206 a and206 b and a side wall 208 that together define a relatively thin housingportion 210 and a relatively thick housing portion 212. An indentation214 is formed in the relatively thick portion 212. The exemplary cover302 includes top walls 304 a and 304 b and a side wall 306 that togetherdefine a relatively thin cover portion 308 and a relatively thick coverportion 310. A portion of the baseplate 350 is not covered by the cover302, thereby defining a recess 312 that is bordered by a wall 314 thatextends around the baseplate (see also FIG. 4B). When the durable anddisposable assemblies 200 and 300 are secured to one another in themanner illustrated in FIG. 1A, the relatively thick portion 212 of thehousing 202 will reside in the recess 312 of the disposable assembly 300(with the wall 314 in the indentation 214). The relatively thin portion210 of the housing 202 will reside on the top wall 304 b of the cover302. The cover 302 also includes a projection 316 that mates with arecess 216 on the housing 202. Additionally, as is discussed in greaterdetail below, the disposable assembly 300 may be configured fordifferent medicaments, such as different medicament concentrations,different medicament amounts, or different modes of system operation.

In other implementations, the cover 302 may be configured to cover fewerthan all of the components on the baseplate 350. For example, a covermay be configured such that the magnetic motor rotor 331 and a portionof the gear train 332 are not under the cover, while the remainingcomponents are under the cover. In still other implementations, thecover 302 may be omitted and the durable assembly 200 may be configuredto cover all of the components on the baseplate 350.

As discussed in U.S. patent publication number 2012/0078170 describedabove, and in U.S. application Ser. No. 13/300,574, filed Nov. 19, 2011,and corresponding U.S. patent publication number 2012/0184907, and inU.S. application Ser. No. 13/475,843, filed May 18, 2012, andcorresponding U.S. patent publication number 2013/0138078, each of whichare incorporated by reference in their entireties, ambulatory infusionsystems that employ a reservoir on a baseplate may be configured fordifferent types of use. For example, disposable assembly 300 may beadhered to the patient's skin and may be used in conjunction with acannula (not shown) that is operatively connected to the reservoir 336so that the system 100 may be deployed as a “patch-pump,” as shown inFIG. 2A. Alternatively, as shown in FIG. 2B, the baseplate 350 ofdisposable assembly 300 may be configured to operably connect thereservoir 336 to an infusion set 503 (e.g., by way of the illustratedinfusion set tube and a connector 501 shown in FIGS. 1B and 2) so thatthe system 100 may be deployed as a “pocket pump,” a “belt-worn pump” orsome other wearable pump. In other words, using the same durableassembly 200, the user may configure the system for use as “pocket pump”or a “patch pump” by simply selecting the appropriate disposableassembly and attaching the disposable assembly to the durable assembly.The user may also switch from one configuration to another, by simplyremoving one disposable assembly and replacing it with anotherdisposable assembly.

It should therefore be noted that the present inventions include kitsthat contain various combinations of disposable assemblies, where atleast two of the disposable assemblies may be different. Additionally oralternatively, kits or other packages may include various disposableassembly components, such as an infusion set and/or cannula inserter.Kits may also include a durable assembly. The disposable assemblies insuch kits may also include the detection/identificationinstrumentalities discussed below. The components of the present kits(e.g., combination of various disposable assemblies and/or components)may be stored in a common package, with individual packages for eachcomponent if necessary, and provided to the user in the common package.Other components that may be provided in such kits include, but are notlimited to, inserters that are preloaded with a cannula, and cleaningswabs. A recharger may also be provided in a kit that includes a durableassembly.

In addition to disposable assembly packaging and labeling, the differentdisposable assemblies may include visual cues to differentiate thevarious disposable assemblies. For instance, disposable assemblies withdifferent concentrations of medicament or different medicament fillvolumes may use different colors for the reservoir and/or baseplate ofthe disposable assembly, or mechanical features that ensure disposablesare only able to attach to correctly programmed durables.

It should also be noted here that, but for the issue of priming, thedispensing procedures associated with an infusion system “patch pump”configuration, which may include a durable assembly 200 and a disposableassembly 300, are substantially the same as the dispensing proceduresassociated with a “pocket pump” configuration, which may also include aninfusion set 503 (see FIG. 2B). With a “patch pump” configuration,priming is not necessary because the volume of the associated cannulawill be very small and there is a direct connection between the cannulaand the medicament reservoir. Priming is, however, required to fill theinfusion set tube (FIG. 2B) in a “pocket pump” configuration prior tothe onset of medicament delivery. For instance, 20-30 μl may be requiredto fill the entire infusion set tube and, accordingly, the primingprocedure may involve the rapid delivery of 10-15 IUs of U-500 insulinto the tube. The present inventors have determined that it would beadvantageous to prevent users from initiating a priming procedure whenthe system is in the “patch pump” configuration, with a cannulapositioned to deliver medicament essentially directly from themedicament reservoir to the patient, because rapidly delivering 10-15IUs of insulin to the patient could adversely affect patient health.

To prevent such undesirable outcomes, and for user convenience in othersituations involving the choice between a variety of disposableassemblies (such as disposable assemblies with reservoirs containingdifferent medicaments, different concentrations of a medicament, and/orvarying amounts of medicaments), at least some of the present disposableassemblies may be provided with a baseplate identification device and atleast some of the present disposable assemblies may be provided withstructure that cooperate with a baseplate identification device in sucha manner that the durable assembly microprocessor/controller can make a“baseplate type” determination. Exemplary baseplate identificationinstrumentalities and methodologies may be as described inaforementioned U.S. patent publication numbers 2012/0078170,2012/0184907, and 2013/0138078. In addition, baseplate identificationmay be performed mechanically. For instance, a pin or rib may preventattachment of certain disposable assemblies with certain durableassemblies. Additionally or alternative, certain durable assemblies willsimply not function with certain disposable assemblies.

Alternatively, the patient or a clinician may program the system, suchas via a remote control, to indicate the type of disposable assemblyattached. In a manner such as this, a patient can access a variety ofmedicaments for use with a single durable assembly.

Once the “baseplate type” determination is made (e.g., “patch pump”disposable assembly 300 versus a “pocket pump” with infusion set 503attached), the durable assembly will proceed in a manner, or mode ofoperation, that is appropriate for the attached disposable assembly. Forexample, if “patch pump” disposable assembly 300 is detected, thedurable assembly controller will not include priming as part of thedelivery process and, in some implementations, will prevent the userfrom manually implementing a priming procedure. If, on the other hand, a“pocket pump” disposable assembly is detected, then the delivery processmay include appropriate priming of the infusion set tube.

Whether configured as a “pocket pump” or a “patch pump,” the system maybe configured to provide basal delivery of medicament in accordance witha delivery profile provided by a physician by way of a clinician'sprogramming unit. For example, the system may include a program thatstores a number of delivery profiles (e.g., delivery profiles associatedwith a 24-hour delivery cycle, delivery profiles for particularsituations such as sleep or illness, and the like). Each deliveryprofile specifies multiple doses (or pump “operations”) over time, e.g.,a particular number of doses at particular times or a particular numberof doses per unit time. In some implementations, a dose may be thevolume associated with the minimum controllable displacement of theplunger 335. The system may also be configured to provide bolus deliveryin response to an instruction from a patient remote control 1000 (FIG.2A). A bolus instruction may come in response to a high glucose levelmeasurement in the case of a diabetic patient, an increase in pain levelin the case of a pain management patient, or some other symptom. Thesystem may also be configured to perform other functions, such as endingmedicament delivery in response to instructions from patient remotecontrol 1000.

The present infusion pumps may be used in conjunction with a widevariety of remote controls. Such remote controls may be used to, forexample, allow the user to transmit instructions to the durable assembly200 or facilitate communication between durable assembly 200 and theuser (e.g., an alarm condition message or other message concerning theconditions of system 100). An exemplary remote control 1000 (FIG. 2A)may be configured to facilitate one, some, or all of the followingoperations: (1) turning the remote control 1000 on or off, (2)associating (or “assigning”) the remote control 1000 to the durableassembly 20, (3) obtaining status information such as medicament level,battery charge level, and/or alarm conditions, (4) silencing the durableassembly alarm, (5) selecting options that may be associated with thedurable assembly alarm such as type of alarm (audible, palpable, and/orvisible) and strength/volume of alarm, (6) connecting remote control1000 to a computer to, for example, update remote control or durableassembly firmware, load and delete delivery profiles stored in thedurable assembly or remote control, and otherwise reprogram the durableassembly or remote control, (7) selecting medicament options such asmedicament concentrations, (8) selecting and initiating a storedmedicament delivery profile, (9) increasing and decreasing medicamentdose rate, and/or (10) pausing a dispensing operation. A user may pausedelivery in order to remove or replace a patient applied structure(e.g., a disposable assembly), adjust for a current or anticipatedchanged body condition (e.g., low glucose, vigorous exercise), follow aphysician's suggestion, or disconnect the durable assembly from the bodyfor any other reason.

The exemplary remote control 1000 (FIG. 2A) may be configured togenerate an indicator, based on information from a microprocessor 223for durable assembly 200, that is indicative of, for instance, theamount of time remaining in the current dispensing program, the amountof time until the next disposable assembly replacement, etc. Theindicator may be audible, visible, palpable, or combinations thereof. Atime remaining indicator may be useful for a variety of reasons. Forexample, knowledge of the time remaining prior to next disposableassembly replacement allows the patient to determine, based at least inpart on the current time of day and upcoming events (e.g., travel orsleep), whether or not it would be more convenient to replace thedisposable assembly at a time prior to the end of the dispensingprogram.

As described above, parts of the present systems may be considered thereusable parts, while other parts may be considered the disposableparts. In the illustrated embodiments, the durable assembly 200, whichmay include structures such as microprocessor 223 and coil assembly 224,is reusable, while exemplary disposable assemblies 300, which mayinclude structures such as a motor rotor 331 and reservoir 336 on abaseplate 350, are disposable.

With respect to dimensions, some embodiments of the exemplary infusionpump system 100 may have the following dimensions: length dimensions of35 mm+/−1.0 mm, 35 mm+/−0.10 mm, or 35 mm+/−5.0 mm; width dimensions of30 mm+/−1.0 mm, 30 mm+/−0.10 mm, or 30 mm+/−5 mm; and overall thicknessor height dimensions of 8.5 mm+/−1.0 mm, 8.5 mm+/−2 mm, or 8.5 mm+/−0.10mm. Suitable housing materials include, but are not limited to, plasticor other materials having a modulus of elasticity of 0.2-1.0 millionpsi.

Exemplary durable assembly microprocessors and associated circuitry;rechargeable batteries and associated battery rechargers and rechargingmethods; battery and recharging management; temperature sensors; andexemplary alarms and alarm conditions are described in more detail inaforementioned U.S. patent publication numbers 2012/0078170,2012/0184907, and 2013/0138078.

The reservoirs may also be, but are not required to be, prefilled.Prefilled reservoirs are advantageous for a variety of reasons. By wayof example, but not limitation, some users prefer to avoid reservoirfilling procedures because they are inconvenient and tend to involveneedles. User-based refilling also increases the likelihood that airbubbles will be introduced into the reservoir, while prefilling by themanufacturer of the reservoir and/or the medicament can be accomplishedwithout any substantial introduction of air bubbles using, for example,a vacuum filling procedure. A variety of exemplary medicamentreservoirs, including pressure sensors (such as for sensing occlusion)and other sensors, are described in more detail in aforementioned U.S.patent publication numbers 2012/0078170, 2012/0184907, and 2013/0138078.

Turning now to FIGS. 3A and 3B, an exemplary durable assembly 200 mayinclude a power source such as one or more batteries 221, temporarypower storage such as one or more capacitors 222 (see FIGS. 2 and 5B), acontroller such as microprocessor 223, a coil assembly 224, and a halleffect sensor 225. Those of skill in the art will appreciate thatincluding the motor's coil assembly 224 and all other electronics withinthe durable assembly 200 reduces the cost and complexity of disposableassembly 300. In addition, the microprocessor 223 provides flexibilityto include features such as user data storage, programs,programmability, adjustability, a display, buttons, wirelesscommunication protocols, or the like to the pump 100. Durable assembly200 may also be molded with locking features that snap onto thedisposable assembly 300, but that also allow removal of the durableassembly 200 from the disposable assembly 300 either while thedisposable assembly remains in place on the patient (after medicamentdelivery has been paused), or after the entire system has been removedfrom the patient.

The power source may be one or more commercially available batteries,such as a commercially available zinc-air battery or lithium polymerbattery. The batteries may be selected to have sufficient capacity tooperate the system for certain delivery amounts or delivery times, suchas for over 400 units of delivered insulin. The optional power storagemay be one or more commercially available capacitors or super-capacitorsor other temporary storage device(s).

Turning now to FIGS. 4A and 4B, an exemplary disposable assembly 300 mayinclude baseplate 350 and components such as a reservoir 336, a plunger335 within the reservoir and connected to lead screw 334, and a magneticmotor rotor 331 mechanically attached through gear train 332 to affectrotation of the lead screw drive gear 333, which causes translation ofthe lead screw 334 and plunger 335 within reservoir 336. The cover 302is positioned over these components in the illustrated embodiment. Theexemplary baseplate 350 includes an adhesive backing for attachment tothe patient with a removable adhesive cover. The baseplate 350 may alsobe molded with baseplate locking features that snap onto the durableassembly 200 (such as magnets molded into the housings of eachassembly), and that also allows removal of the durable assembly 200 fromthe disposable assembly 300.

Referring to FIGS. 2 and 4B, the exemplary reservoir 336 includes abarrel 338 with an inner surface 340 defining a fluid storage volume 342and an oval cross-section, but other shapes are possible. A plunger 335with a matching cross-sectional shape fits within the barrel and carriesa fluid seal such as, but not limited to, o-rings, to seal themedicament within the storage volume 342. The exemplary plunger 335 isformed from rubber and includes three o-ring seals. The reservoir 336includes a connector 501 that may be used for filling reservoir 336, orfor attaching a cannula for “patch-pump” type configurations, or forconnecting (potentially via an appropriate adapter(s)) an infusion setfor “pocket-pump” type configurations. The plunger 335 moves within thebarrel 338 to vary the volume of medicament within the storage volume342. Reservoir 336 may be, for instance, prefilled with U-500 insulin invarious volumes to suit the patient use profile. A plug may be insertedin the connector 501 to maintain a sterile environment until use. Thepatient would remove the plug prior to use, in those instances.

Additional exemplary baseplates for use with the disposable assembliesof the present inventions, as well as exemplary cannula designs, fluidicconnection between a medicament reservoir and the cannula, cooperationbetween the cannula and disposable assemblies (for instance, to preventaxial movement of the cannula relative to the baseplate and patient),attachment of an infusion set to the reservoir of the disposableassembly, configurations and uses of a non-delivery baseplate,arrangements and structures for attaching disposable and durableassemblies, skin adhesive designs, and various occlusion sensors, may beas described in U.S. patent application Ser. No. 12/890,207, filed Sep.24, 2010 and corresponding U.S. patent publication number 2012/0078170,as well as aforementioned U.S. patent publication numbers 2012/0184907and 2013/0138078.

Turning now to FIGS. 5A-5C and the illustrated two-piece motor, themotor's coil assembly 224 (and a Hall effect sensor 225) of the durableassembly 200 are positioned above the magnetic motor rotor 331 that ispart of the disposable assembly 300. An exemplary multi-pole motor rotor331 may be disc-shaped and have a 9.8 mm outer diameter, 5.2 mm innerdiameter, and 0.8 mm thickness. Another example motor rotor may have an11 mm outer diameter, 5 mm inner diameter, and 1.2 mm thickness.Multi-pole motor rotors of this type typically cost less than 5 centsper piece, helping control the total cost of disposable assembly 200.The motor rotor 331 is also parallel to the baseplate 350, i.e., themotor rotor axis of rotation is perpendicular to the baseplate, in theillustrated embodiment. The microprocessor 223 directs rotation of motorrotor 331 by sequentially energizing the coils of motor coil assembly224 to create an electromagnetic torque coupling between the motor coilassembly 224 and the motor rotor 331. The position/orientation of therotor's poles relative to the rotating magnetic field generator (coilassembly 224) is measured by back EMF, a rotary encoder, a hall effectsensor 225 (FIG. 5A), or the like. For instance, a Hall effect sensormounted on the coil windings may be used to supply the microprocessor acount, a tachometer signal, or rotor position, allowing low-costclosed-loop control of the rotor speed. Brushless motors of this typeare typically 85-90% or more efficient, and run very cool. While theremay be variations in construction, the face-to-face stator coils andflat rotor plate shown in FIGS. 5A-5C provide a compact design. Inaddition, more coils and/or Hall effect sensors may be used.

As can best be seen in FIG. 6, between the motor coil assembly 224 andmotor rotor 331 is a gap 240. Some or all of the gap 240 may be definedby (and occupied by) portions of the housing 202 and the cover 302,i.e., the housing bottom wall 206 a and the cover top wall 304 b in theillustrated implementation. In other implementations, the gap 240between the between the motor coil assembly 224 and motor rotor 331 maybe occupied by only a portion of the durable assembly housing, or only aportion of the disposably assembly cover, or no structure at all and maysimply be an air gap. The size of the gap, which is defined by thedistance between the motor coil assembly 224 and the motor rotor 331, istypically about 0.5 mm to 2.0 mm. As such, there is no gear engagementor other mechanical connection between the durable assembly 200 anddisposable assembly 300. And as described earlier, all electronics maybe positioned within the durable assembly 200, with the energy needed bythe disposable assembly 300 transferred by electromagnetic torquecoupling, which is a coupling without direct mechanical coupling orelectrical contact from the durable assembly 200. This exemplary designaffords the additional advantage of being relatively simple to makewaterproof, or at least water resistant.

As described above, rotation of motor rotor 331 drives gear train 332,causing rotation of lead screw drive gear 333, which in turn affectstranslation of the lead screw 334 and plunger 335, which is attached tolead screw 334. In this manner, electromagnetically generated torque iscreated when electromagnetic energy supplied by durable assembly 200 istransformed into mechanical forces within the disposable assembly 300that advance plunger 335. A ratchet (not shown) or other similar devicemay be used to prevent back drive of gear train 332. As plunger 335 isdriven through reservoir 336, medicament is dispensed precisely,corresponding to the precision movements of the gears and motor rotor.With the entire gear train, lead screw drive gear, lead screw, andplunger all permanently contained in the disposable assembly 300, thereis no need to retract any plunger components into the durable assembly200 prior to separation from the disposable assembly 300. As a result, afurther advantage of this exemplary design is greatly reduced energyconsumption, which allows use of, for instance, a primary battery(ies)as a power source.

Use of an exemplary system 100 will now be described. At the most basiclevel, a patient's use of the exemplary infusion pump systems (e.g.,system 100 in FIGS. 1A-2B) involves obtaining a new disposable assembly300, connecting the disposable assembly to the durable assembly 200,peeling the liner from the baseplate adhesive layer, gainingsubcutaneous access, and initiating a medicament delivery operation. Insome instances, use may involve additional steps such as attaching acannula to connector 501 of the disposable assembly and removing acannula cap, if necessary. Various aspects of the basic operation of thepresent systems are described below. Operation of a system does notnecessarily require all of the steps each time the system is deployed,and the order of some of the steps may be changed. Operation is alsodiscussed below, in the exemplary context of the above-described durableassembly 200 and disposable assembly 300 used as a patch pump, throughthe use of a flow chart (FIG. 8). The discussion is, however, equallyapplicable to other patch pump implementations, as well as to pocketpump implementations with minor variations. Also, unless otherwiseindicated, the actions and determinations performed by the durableassembly 200 are controlled by the durable assembly microprocessor andfurther references to the controller are limited in the interest ofbrevity.

Referring to FIG. 8, use of the present systems may involve removal of adisposable assembly from a durable assembly and the replacement of thedisposable assembly. This may occur when the medicament reservoir isempty (as described in more detail in U.S. patent application Ser. No.12/890,207 and corresponding U.S. patent publication number2012/0078170) (Step S101) and a “replace disposable assembly” message oralert is presented (Step S102), or when the durable assembly controllerreceives a user-initiated “replace disposable assembly” signal from aremote control 1000 (Step S103). The user may desire to replace adisposable assembly before the medicament reservoir is empty for avariety of reasons such as, for example, to accommodate the user's sleepor travel schedule, when the medicament exhibits a loss ofeffectiveness, when a dispensing problem arises, or due to a prescribedchange in medicament.

The user may then obtain, possibly from storage in a refrigeratordepending on medicament requirements, a new disposable assembly 300(Step S104). The durable assembly 200 and disposable assembly 300 maythen be removed from the skin, separated, and the disposable assembly300 discarded (Steps S106 and S107).

Next, the new disposable assembly 300 may be attached to the durableassembly 200 (Step S109). The user should clean the skin surface S ontowhich the baseplate 350 of disposable assembly 300 will be adhered (FIG.7, and Step S116 of FIG. 8). Then the user peels off the baseplateadhesive liner to expose the baseplate adhesive layer (Step S117) andremoves cannula cap (when present) (Step S118). In the exemplary use ofFIG. 8, the disposable assembly 30 is supplied with a cannulapre-attached to the connector 501. In other embodiments, a cannulainserter may be attached to the system, which may be triggered to insertthe cannula after the system in placed against the skin. Exemplaryinserters are described in U.S. patent publication number 2013/0138078.

Returning to the steps in FIG. 8, the system 100 including durableassembly 200 and disposable assembly 300 may be positioned over asuitable body location and pressed gently to adhere the adhesive layerto the skin surface S (Step S119). Finally, if necessary, the remotecontrol 1000 may be used to initiate a particular medicament deliveryoperation (Step S120). The delivery operation may follow a predetermineddelivery profile (e.g. a particular basal rate, a series of time-spacedbolus deliveries, or some combination thereof) that is equated to motorrotor rotations, at particular rates and times, required to delivermedicament in accordance with the profile. Alternatively, the profilemay be input by the user with the remote control 1000 and stored by thedurable assembly microprocessor. For example, the remote control maystore a number of different delivery profiles and bolus deliveries fromwhich the patient can choose. Such profiles may correspond to, forexample and depending on the medicament, days where vigorous exercise isexpected, days where it is not, incidences of increased pain, etc.Alternatively, or in addition, the profile stored in the durableassembly microprocessor may be set by a clinician's programming unit. Insuch a case, as in the case of different disposable assemblies 300provided with different specified delivery rates, a remote control maynot be needed to initiate, e.g., basal delivery.

The discussion above is also applicable to use of the “pocket pump”system as shown in FIG. 2B. Minor variations in the above-describedprocedure include, for example, use of an infusion set 503 instead of acannula, attaching the infusion set to connector 501, potentially via anadapter (which may vary with the type of infusion set 503), and primingof the infusion set tube.

Another exemplary ambulatory infusion system, which is generallyrepresented by reference numeral 100 a in FIG. 9, includes a durableassembly 200 a and a disposable assembly 300 a. System 100 a issubstantially similar to system 100. Here, however, the intersection ofthe top walls is primarily linear. Additionally, the disposable assembly300 a has a recess 316 a which mates with a corresponding projection 216a on the durable assembly 200 a. The projection 216 a and recess 316 aare located at the outer perimeter of the assembled system 100 a.

Various methodologies are presented here in the context of the exemplarystructures described in the preceding sections, and illustrated in thevarious figures, for the purpose of explanation only. Although thepresent methodologies may employ the structures described above, theyare not limited thereto. Additionally, the durable assembly may provideaudible, visible and/or tactile notifications. A remote control may alsoprovide audible, visible and/or tactile notifications as an alternativeto, or in addition to, any notifications provided by a durable assembly.Additionally, embodiments of the present inventions may incorporate anyone, combinations of less than all, or all of the methodologies ordevices referenced above.

Although the inventions disclosed herein have been described in terms ofthe preferred embodiments above, numerous modifications and/or additionsto the above-described preferred embodiments would be readily apparentto one skilled in the art. It is intended that the scope of the presentinventions extends to all such modifications and/or additions and thatthe scope of the present inventions is limited solely by the claims setforth below or later added.

Finally, with respect to terminology that may be used herein, whether inthe description or the claims, the following should be noted. The terms“comprising,” “including,” “carrying,” “having,” “containing,”“involving,” and the like are open-ended and mean “including but notlimited to.” Ordinal terms such as “first”, “second”, “third,” do not,in and of themselves, connote any priority, precedence, or order of oneelement over another or temporal order in which steps of a method areperformed. Instead, such terms are merely labels to distinguish oneelement having a certain name from another element having a same name(but for the ordinal term) to distinguish the elements. “And/or” meansthat the listed items are alternatives, but the alternatives alsoinclude any combination of the listed items. The terms “approximately,”“about,” “substantially” and “generally” allow for a certain amount ofvariation from any exact dimensions, measurements, and arrangements, andshould be understood within the context of the description and operationof the invention as disclosed herein. Terms such as “top,” “bottom,”“above,” and “below” are terms of convenience that denote the spatialrelationships of parts relative to each other rather than to anyspecific spatial or gravitational orientation. Thus, the terms areintended to encompass an assembly of component parts regardless ofwhether the assembly is oriented in the particular orientation shown inthe drawings and described in the specification, upside down from thatorientation, or any other rotational variation therefrom.

I claim:
 1. An infusion pump system, comprising: a durable assemblyincluding an energy supply; and a disposable assembly including amedicament reservoir; wherein the durable assembly and the disposableassembly are configured to be attached to one another in such a mannerthat energy needed to dispense medicament from the medicament reservoiris supplied by the energy supply and transferred from the durableassembly to the disposable assembly without direct mechanical couplingor electrical connection.
 2. An infusion pump system as claimed in claim1, wherein the energy is transferred through electromagnetic torquecoupling.
 3. An infusion pump system as claimed in claim 1, wherein thedurable assembly includes a coil assembly that receives energy from theenergy supply; the disposable assembly includes a magnetic motor rotorpositioned adjacent to the coil assembly; and energization of the coilcauses the motor rotor to rotate.
 4. An infusion pump system as claimedin claim 3, wherein the coil assembly and the magnetic motor rotor areseparated by a gap.
 5. An infusion pump system as claimed in claim 4,wherein the durable assembly includes a housing and a portion of thehousing is located in the gap.
 6. An infusion pump system as claimed inclaim 4, wherein the disposable assembly includes a baseplate and acover and a portion of the cover is located in the gap.
 7. An infusionpump system as claimed in claim 4, wherein the gap is 0.5 mm to 2.0 mm.8. An infusion pump system as claimed in claim 3, wherein the medicamentreservoir includes a barrel and a plunger within the barrel; and themagnetic motor rotor is mechanically coupled to the plunger.
 9. Aninfusion pump system as claimed in claim 1, wherein the energy supplyincludes a battery.
 10. An infusion pump system as claimed in claim 9,wherein the battery comprises either one or more primary cell batteries,or one or more rechargeable batteries.
 11. A method, comprising the stepof: securing an infusion pump durable assembly with an energy supply toan infusion pump disposable assembly with a medicament reservoir suchthat energy from the energy supply is transferred to the disposableassembly without direct mechanical coupling or electrical connection andtransformed into mechanical forces that move a plunger within thereservoir.
 12. A method as claimed in claim 11, wherein the energysupply includes one or more batteries.
 13. A method as claimed in claim11, wherein the durable assembly includes a coil assembly; thedisposable assembly includes a magnetic motor rotor; and the step ofsecuring the infusion pump durable assembly to the infusion pumpdisposable assembly comprises securing the infusion pump durableassembly to the infusion pump disposable assembly such that there is agap between coil assembly and the magnetic rotor.
 14. A method asclaimed in claim 13, wherein a portion of at least one of the durableassembly and the disposable assembly is located within the gap.
 15. Amethod as claimed in claim 11, wherein energy is transferred from theenergy supply to the disposable assembly through electromagnetic torquecoupling.
 16. A disposable assembly, comprising: a baseplate; amedicament reservoir on the baseplate; a plunger moveable within thereservoir; a motor rotor that receives electromagnetic energy fromoutside the disposable assembly; and a gear train that transformsrotation of the motor rotor into mechanical forces that move theplunger.
 17. A disposable assembly as claimed in claim 16, wherein thedisposable assembly does not include a motor stator.
 18. A disposableassembly as claimed in claim 16, wherein the motor rotor comprises adisc that is parallel to the baseplate.
 19. A disposable assembly asclaimed in claim 16, wherein the motor rotor is disc-shaped.